Migraine Nervous System Diseases Migraine
Conditions
Interventions
100 participants will be randomly assigned to the verum acupuncture group and the sham acupuncture group. All participants will receive acupuncture for 12 sessions over 4 weeks and 3 months of follow-
Sponsors
Beijing Hospital of Traditional Chinese Medicine affiliated to the Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed as migraine without aura according to the diagnostic criteria specified by the International Classification of Headache Disorders (International Classification of Headache Disorders-Third edition (beta version) [ICHD-IIIß]) 2. History of migraine at least 1 year before study entry 3. More than 2 migraine attacks within 4 weeks 4. Age between 18 and 65 years old and right-handed 5. No acute migraine treatment with acupuncture or drugs within 24 hours after the beginning of the migraine attack, no prophylaxis treatments with acupuncture or drugs in the past 3 months 6. Written informed consent provided
Exclusion criteria
Exclusion criteria: 1. Chronic migraine, tension-type headache, cluster headache, and other primary headaches 2. Secondary headache and other neurological diseases 3. Relatively severe systemic diseases (cardiovascular disease, acute infectious disease, hematopathy,endocrinopathy, allergy, and methysis) 4. Headache caused by otorhinolaryngology diseases or intracranial pathological changes 5. Pregnancy, lactation, or insufficient contraception 6. The use of b-blockers, opioids, antipsychotics, antidepressants, antimaniacals, barbiturates, benzodiazepines, skeletal muscle relaxants, tranquilizers, or tramadols within the last 3 months 7. History of depression, Parkinson’s disease, or other extrapyramidal diseases 8. Magnetic resonance imaging (MRI) contraindications such as claustrophobia and metal objects in patients 9. Not being right-handed as measured by the Edinburgh Handedness Inventory 10. Acupuncture contraindications such as bleeding tendency and local infection 11. Alcohol or drug abusers 12. Participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of migraine days during the 4th and 16th week after randomization. The participants are asked to fill in headache diaries from baseline period (4 weeks before the beginning of treatment) to the 16th week after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Headache impact and quality of life are measured using the Headache Impact Test (HIT-6), the Migraine Disability Assessment questionnaire (MIDAS) and the Migraine-Specific Quality of Life Questionnaire scores MSQ) 2. Anxiety and depression are measured using the Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI) scores,and the State-trait Anxiety Inventory (STAI) 3. Sleep quality is measured using the Pittsburgh Sleep Quality Index (PSQI) 4. Cognitive function is measured using the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) 5. Sense of pain is measured using the Quantitative Sensory Testing (QST) Measured before randomization, 4 and 16 weeks after randomization, and besides the BDI , BAI and QST will be assessed at the first, second and third weeks during treatment. | — |
Countries
China
Contacts
Public ContactLin-Peng Wang
Outcome results
None listed